Prone Positioning During Delayed Cord Clamping

Prone Positioning During Delayed Cord Clamping: A Randomized Control Pilot Study to Identify Optimal Neonatal Positioning During Delayed Cord Clamping

Delayed cord clamping is a routine technique used in the delivery room. The baby remains attached to the umbilical cord and placenta for 30-60 seconds after birth to allow for maximal transfer of oxygen and blood to the newborn. This study seeks to determine the best position (on the back versus on the belly) for the newborn during the 30-60 seconds of delayed cord clamping.

Study Overview

• Status: Recruiting
• Conditions: Delayed Cord Clamping
• Intervention / Treatment: Procedure: Prone Positioning; Procedure: Supine Positioning

Detailed Description

This study is being done to see if placing babies on the stomach or the back during delayed cord clamping after birth will improve the outcomes of preterm babies. Studies have shown that in some instances, positioning on the belly may help newborns clear their respiratory secretions. Research has shown that preterm babies can have improved breathing and require less support when placed on the stomach (prone position) rather than the back (supine position). Currently there are no guidelines for the best position for neonates to be in while receiving delayed cord clamping. The investigators are hoping to complete a research study to determine if placing preterm babies on their stomachs during the time of delayed cord clamping will improve the breathing of preterm babies and reduce the need for additional oxygen support with a breathing tube (endotracheal intubation). Depending on the outcomes of the study, the investigators are hoping to determine which position results in better outcomes for babies in both the delivery room and in the neonatal intensive care unit. If the investigators are able to determine the optimal position in this study, the investigators hope to improve the outcomes for future babies that are born preterm by placing the baby in the optimal position during delayed cord clamping.

• Study Type: Interventional
• Enrollment (Estimated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katelyn Uribe, MD; Phone Number: 717-781-3922; Email: kuribe1@jhmi.edu
• Study Contact Backup: Name: Brittany Schwarz, MD; Phone Number: 716-912-18975; Email: bschwa24@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins University
      • Contact: Mara Rosner, MD MPH; Phone Number: 443-287-9545; Email: mrosner5@jhmi.edu
      • Principal Investigator: Mara Rosner, MD
      • Sub-Investigator: Brittany Schwarz, MD
      • Sub-Investigator: Katelyn Uribe, MD
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • Not yet recruiting
      • West Penn Hospital-Allegheny Health Network
      • Contact: Sanjay Mitra, MD; Phone Number: 412-915-7218; Email: Sanjay.Mitra@ahn.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Pregnant patient admitted for diagnosis that could result in a preterm delivery
• Anticipated gestational age of delivery could be between 25w+0d - 29w+6d
• Fetus without major anomalies or known genetic condition that could impact respiratory status or need for intubation at birth
• Singleton or twin gestation
• Neonate eligible for delayed cord clamping based on institutional protocol
• Patient is able to understand study procedures and is willing and able to consent

Exclusion Criteria:

• Triplet or higher order gestation
• Maternal or fetal/neonatal contraindication to delayed cord clamping

• Major fetal anomaly that would be expected to impact delivery room intubation rates such as:

  • Major congenital cardiac defect (not isolated atrial septal defect/ventricular septal defect)
  • Significant fetal arrhythmia at the time of delivery
  • Fetal tumor
  • Renal anhydramnios (not isolated urinary tract dilation with normal fluid)
  • Congenital Diaphragmatic Hernia
  • Heterotaxy
  • Moderate to severe ventriculomegaly or other major brain malformation (not mild isolated ventriculomegaly)
  • Airway obstruction
  • Underlying genetic disease that could impact respiratory function at delivery
  • Arthrogryposis (not apparently isolated clubbed foot)
  • Skeletal dysplasia
• Pregnant patient is unable to understand study materials or is unwilling or unable to consent
• Acute maternal obstetric emergency that precludes time or maternal focus for the consent process to take place

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Prone Positioning During Delayed Cord Clamping; Newborns delivered between 25w+0d and 29w+6d gestation who have been randomized in 1:1 fashion to prone positioning during routine delayed cord clamping.	Procedure: Prone Positioning; Newborn will be prone position for 30-60 seconds during delayed umbilical cord clamping
Active Comparator: Supine Positioning During Delayed Cord Clamping; Newborns delivered between 25w+0d and 29w+6d gestation who have been randomized in 1:1 fashion to supine positioning during routine delayed cord clamping.	Procedure: Supine Positioning; Newborn will be supine position for 30-60 seconds during delayed umbilical cord clamping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of pre-term neonates that require endotracheal intubation	To determine if deliberate prone positioning of preterm neonates during delayed cord clamping reduces the need for endotracheal intubation in the delivery room.	30-60 seconds immediately after birth of the newborn

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: West Penn Allegheny Health System
• Investigators: Principal Investigator: Mara Rosner, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2022
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 8, 2023
• Last Update Submitted That Met QC Criteria: August 4, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Preterm Birth; Umbilical Cord Clamping; Delayed Cord Clamping (DCC)
• Other Study ID Numbers: IRB00307467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No